Support for HDS v2 Certification
Health Data Host: from diagnosis to certificate issued by a COFRAC-accredited body, we support you on every requirement of the framework. Pragmatic, tailored, hands-on.
Why HDS certification?
HDS certification is not optional: as soon as you host personal health data on behalf of third parties, it becomes a legal requirement under Article L.1111-8 of the French Public Health Code. Several good reasons to tackle it:
Legal requirement
Article L.1111-8 of the French Public Health Code mandates HDS certification for anyone hosting health data on behalf of third parties.
Access to healthcare market
Without HDS, you cannot respond to tenders from healthcare facilities, GHTs, laboratories and public players.
Enhanced security
Availability, backup, traceability, encryption : the framework imposes a solid foundation that truly protects your sensitive data.
Client trust
The HDS certificate reassures editors, healthcare professionals and patients about the handling of their most sensitive data.
Structuring framework
The HDS framework durably structures your security management, far beyond one-off compliance.
Service continuity
Guaranteeing availability and resilience of hosted health data: vital for your clients.
Who is affected by HDS certification?
Any organization that hosts personal health data on behalf of third parties is affected: e-health software editors, health SaaS platforms, datacenters, laboratories, telemedicine players, medtech. The HDS framework, led by the French Health Digital Agency (ANS), distinguishes two main scopes: "physical infrastructure host" and "managed services host", i.e. 6 activities in total. We help you identify precisely the scope that matches your business.
Our methodology 🛠️
The HDS framework rests on a foundation of ISO/IEC 27001, supplemented by healthcare-specific requirements (ISO 20000-1 for service management, availability, backup, traceability, reversibility). Our approach is resolutely pragmatic and personalized: we start from your existing setup, target the right framework activities, and build a realistic plan toaudit by a COFRAC-accredited body. Hands-on, no useless theory.
The 7 steps to HDS v2 certification 📍
Training & Scoping
Training your teams on the HDS framework and choosing scope activities (physical infrastructure and/or managed services).
Gap analysis
Gap analysis between your current state and ANS HDS framework requirements (foundation ISO 27001 + healthcare specificities).
Compliance implementation
Implementation of measures: BCP, backup, encryption, traceability, reversibility, access and incident management.
Dry-run audit
Assessment of your compliance by an auditor to prepare you calmly for the official audit.
Certification audit
Support during the certification audit conducted by a COFRAC-accredited body.
Surveillance & maintenance
Maintaining compliance over time through surveillance audits and certificate renewal.
Verified expertise, not just claimed
BCIT is partner PECB & EXIN, whose certifications (including ISO 27001 Lead Auditor/Implementer) require examination and ongoing competency maintenance. Our consultants don't discover your framework with you.
Why choose BCIT for your HDS?
Certified expertise
Our specialists master the foundation ISO 27001 and healthcare requirements of the HDS framework. A field expert, not a generalist consultant.
Personalized approach
We calibrate the HDS scope to your business to avoid certifying what doesn't need to be.
Estimate your certification price
Interactive calculator: company size, sector, additional compliances... get a price range in a few clicks.
Price estimate
If certification is not obtained due to our actions, we refund the entire amount paid.
Ready to launch your HDS certification?
Let's take 15 minutes for an initial discussion. We'll understand your business, the HDS scope that concerns you, and propose personalized and realistic support.
Support for HDS v2 Certification
Health Data Host: from diagnosis to certificate issued by a COFRAC-accredited body, we support you on every requirement of the framework. Pragmatic, tailored, hands-on.
Why HDS certification?
HDS certification is not optional: as soon as you host personal health data on behalf of third parties, it becomes a legal requirement under Article L.1111-8 of the French Public Health Code. Several good reasons to tackle it:
Legal requirement
Article L.1111-8 of the French Public Health Code mandates HDS certification for anyone hosting health data on behalf of third parties.
Access to healthcare market
Without HDS, you cannot respond to tenders from healthcare facilities, GHTs, laboratories and public players.
Enhanced security
Availability, backup, traceability, encryption : the framework imposes a solid foundation that truly protects your sensitive data.
Client trust
The HDS certificate reassures editors, healthcare professionals and patients about the handling of their most sensitive data.
Structuring framework
The HDS framework durably structures your security management, far beyond one-off compliance.
Service continuity
Guaranteeing availability and resilience of hosted health data: vital for your clients.
Who is affected by HDS certification?
Any organization that hosts personal health data on behalf of third parties is affected: e-health software editors, health SaaS platforms, datacenters, laboratories, telemedicine players, medtech. The HDS framework, led by the French Health Digital Agency (ANS), distinguishes two main scopes: "physical infrastructure host" and "managed services host", i.e. 6 activities in total. We help you identify precisely the scope that matches your business.
Our methodology 🛠️
The HDS framework rests on a foundation of ISO/IEC 27001, supplemented by healthcare-specific requirements (ISO 20000-1 for service management, availability, backup, traceability, reversibility). Our approach is resolutely pragmatic and personalized: we start from your existing setup, target the right framework activities, and build a realistic plan toaudit by a COFRAC-accredited body. Hands-on, no useless theory.
The 7 steps to HDS v2 certification 📍
Training & Scoping
Training your teams on the HDS framework and choosing scope activities (physical infrastructure and/or managed services).
Gap analysis
Gap analysis between your current state and ANS HDS framework requirements (foundation ISO 27001 + healthcare specificities).
Compliance implementation
Implementation of measures: BCP, backup, encryption, traceability, reversibility, access and incident management.
Dry-run audit
Assessment of your compliance by an auditor to prepare you calmly for the official audit.
Certification audit
Support during the certification audit conducted by a COFRAC-accredited body.
Surveillance & Maintenance
Maintaining compliance over time through surveillance audits and certificate renewal.
Verified expertise, not just claimed
BCIT is partner PECB & EXIN, whose certifications (including ISO 27001 Lead Auditor/Implementer) require examination and ongoing competency maintenance. Our consultants don't discover your framework with you.
Why choose BCIT for your HDS?
Certified expertise
Our specialists master the foundation ISO 27001 and healthcare requirements of the HDS framework. A field expert, not a generalist consultant.
Personalized approach
We calibrate the HDS scope to your business to avoid certifying what doesn't need to be.
Estimate your certification price
Interactive calculator: company size, sector, additional compliances... get a price range in a few clicks.
Price estimate
If certification is not obtained due to our actions, we refund the entire amount paid.
Ready to launch your HDS certification?
Let's take 15 minutes for an initial discussion. We'll understand your business, the HDS scope that concerns you, and propose personalized and realistic support.